Infections, StreptococcalPhase 2NCT00896064

Evaluation of a Booster Dose of Pneumococcal Vaccine Formulations in Young Adults

A Phase 2 study testing Pneumococcal vaccine GSK2189242A (formulation 1) and Pneumococcal vaccine GSK2189242A (formulation 2) in people with Infections, Streptococcal, run by GlaxoSmithKline at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of a booster dose of pneumococcal vaccines (GSK 2189242A) in young adults. This protocol posting deals with objectives \& outcome measures of the booster phase. Read more about this study

Who is it for?: Ages 18 to 41 yearsHealthy volunteers can take part
Conditions the study is for: Infections, Streptococcal
What is being tested?: Pneumococcal vaccine GSK2189242A (formulation 1) and Pneumococcal vaccine GSK2189242A (formulation 2)
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 43 participants
Where: 1 siteBelgium
Study dates: 18 May 2009to 5 Aug 2009
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 41 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Subjects who the investigator believes will comply with the requirements of the protocol should be enrolled in the study.
A male or female between, and including, 18 and 41 years old at the time of vaccination.
Subjects who previously participated in the study NCT00707798 and received one of the two investigational GSK2189242A vaccine formulations during the primary study.
Written informed consent obtained from the subject.
Free of obvious health problems as established by medical history, clinical examination and clinical laboratory assessment before entering into the study.
Female subjects of non-childbearing potential (defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause) may be enrolled in the study.

Show all 10Show fewer

Female subjects of childbearing potential may be enrolled in the study, if the subject:
has practiced adequate contraception for 30 days prior to vaccination, and
has a negative pregnancy test on the day of vaccination, and
has agreed to continue adequate contraception during the entire treatment period and for 2 months after vaccination.

Who cannot join

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the vaccination, or planned use during the study period.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to vaccination.
Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting 30 days prior to the vaccination and ending one month (minimum 30 days) after vaccination.
Administration of any pneumococcal vaccine other than the study vaccine during the period between end of study NCT00707798 and study vaccination.
Bacterial pneumonia within the period between end of study NCT00707798 and study vaccination.
Invasive pneumococcal disease (IPD) within the period between end of study NCT00707798 and study vaccination.

Show all 21Show fewer

Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection (no laboratory testing required).
History of thrombocytopenia or bleeding disorder.
Anaphylactic reaction following the previous administration of the vaccine or history of reactions or allergic disease likely to be exacerbated by any component of the vaccine.
Current serious neurologic or mental disorders.
Inflammatory processes such as known chronic active infections (e.g. Hepatitis B, C).
All past or current malignancies (excluding non-melanic skin cancer) and lymphoproliferative disorders.
Acute disease at the time of enrolment/vaccination.
Fever at the time of vaccination. Fever is defined as temperature >= 37.5°C on oral setting.
Physical examination positive for acrocyanosis, jaundice, splenomegaly.
Acute or chronic, clinically significant anaemia, pulmonary, cardiovascular, hematologic, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests, at the discretion of the investigator
Administration of immunoglobulins and/or any blood products within the three months preceding vaccination or planned administration during the study period.
Pregnant or lactating female.
Female planning to become pregnant or planning to discontinue contraceptive precautions.
History of chronic alcohol consumption and/or drug abuse.
Other conditions that the principal investigator judges may interfere with study findings.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

GSK Investigational Site
Ghent, 9000

Other trials in Belgium

About this study

Official title: A Study to Evaluate Safety and Immunogenicity of a Booster Dose of Two Formulations of GSK Biologicals' Pneumococcal Candidate Vaccine in Healthy Young Adults

The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of a booster dose of pneumococcal vaccines (GSK 2189242A) in young adults.

This protocol posting deals with objectives \& outcome measures of the booster phase. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT 00707798)

Conditions: Infections, Streptococcal
Being tested: Pneumococcal vaccine GSK2189242A (formulation 1), Pneumococcal vaccine GSK2189242A (formulation 2)
Keywords: Pneumococcal vaccine, Streptococcus pneumoniae, Young adults
Medical subject headings: Streptococcal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pneumococcal vaccine GSK2189242A (formulation 1)Biological
One dose will be administered intramuscularly at Study Day 0.
Pneumococcal vaccine GSK2189242A (formulation 2)Biological
One dose will be administered intramuscularly at Study Day 0.

Study groups in NCT00896064
Study group	Role	What they receive
Formulation 1	Experimental	Not described Receives: Biological: Pneumococcal vaccine GSK2189242A (formulation 1)
Formulation 2	Experimental	Not described Receives: Biological: Pneumococcal vaccine GSK2189242A (formulation 2)

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Subjects With Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Grade 3 pain = significant pain at rest, pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.
Measured: During the 7-day (Days 0-6) post-booster vaccination period
Number of Subjects With Grade 3 and Vaccine-related Solicited General Symptoms
Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (nausea, vomiting, diarrhoea and/or abdominal pain), headache, malaise, myalgia and fever [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = general symptom assessed by the investigator to be casually related to the study vaccination.
Measured: During the 7-day (Days 0-6) post-booster vaccination period
Number of Subjects With Grade 3 and Vaccine-related Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Measured: During the 31-day (Days 0-30) post-booster vaccination period
Number of Subjects With Any Vaccine-related Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Measured: During the entire study period (from Day 0 to Day 30)
Number of Subjects With Grade 3 Haematological or Biochemical Abnormalities
Among haematological or biochemical abnormalities assessed were: Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Cholesterol, Creatine Phosphokinase (CRP), Hemoglobin decrease, Haemoglobin, Lactate dehydrogenase (LDH), Neutrophils, Red blood cells (RBC), Reticulocytes, White blood cells (WBC) and Overall parameters.
Assessment of intensity: Grading of the haematological and biochemical parameters was performed using the standard Food and Drug Administration (FDA) Toxicity Grading Scale. Changes compared to normal reference ranges were graded: Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening
Measured: At Days 1 and 6 post-booster vaccination

Secondary outcomes (7)

Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (dPly) and Histidine Triad Protein D (PhtD) Proteins
Anti-dPly and anti-PhtD antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in LU/mL. The reference seropositivity cut-off values were equal to or above (≥) 599 LU/mL for anti-dPly and ≥ 391 LU/mL for anti-PhtD.
Measured: Prior to the booster vaccination (Day 0) and one month post-booster vaccination (Day 30)
Titers for Antibodies Against Pneumolysin Haemolysis (Hem-dPly) Protein
Antibody titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 6.
Measured: Prior to the booster vaccination (Day 0) and one month post-booster vaccination (Day 30)
Number of Subjects With Any Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Measured: During the 7-day (Days 0-6) post-booster vaccination period
Number of Subjects With Any Solicited General Symptoms
Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (nausea, vomiting, diarrhoea and/or abdominal pain), headache, malaise, myalgia and fever [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade.
Measured: During the 7-day (Days 0-6) post-booster vaccination period
Number of Subjects With Any Unsolicited AEs
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Measured: During the 31-day (Days 0-30) post-booster vaccination period
Number of Subjects With Any SAEs
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Measured: During the entire study period (from Day 0 to Day 30)
Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities
Among haematological or biochemical abnormalities assessed were: Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Cholesterol, Creatine Phosphokinase (CRP), Hemoglobin decrease, Haemoglobin, Lactate dehydrogenase (LDH), Neutrophils, Red blood cells (RBC), Reticulocytes, White blood cells (WBC) and Overall parameters.
Assessment of intensity: Grading of the haematological and biochemical parameters was performed using the standard Food and Drug Administration (FDA) Toxicity Grading Scale. Changes compared to normal reference ranges were graded: Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening
Measured: At 1 and 6 days post-booster vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 May 20095 Aug 2009

First posted11 May 2009 (estimated)
Study start18 May 2009
Primary completion5 Aug 2009
Study completion5 Aug 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Infections, StreptococcalStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 43 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00896064
Sponsor's protocol ID: 112993
Status last verified: Apr 2017
First submitted: 7 May 2009
Last updated: 17 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Infections, Streptococcal trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Evaluate Safety and Immunogenicity of a Booster Dose of Two Formulations of GSK Biologicals' Pneumococcal Candidate Vaccine in Healthy Young Adults
ClinicalTrials.gov ID: NCT00896064
Acronym / sponsor ID: 112993
Conditions: Infections, Streptococcal
Keywords: Pneumococcal vaccine, Streptococcus pneumoniae, Young adults
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 43 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 18 May 2009
Primary completion: 5 Aug 2009 (actual)
Study completion: 5 Aug 2009 (actual)
First posted: 11 May 2009 (estimated)
Results: Posted 19 Jul 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of a booster dose of pneumococcal vaccines (GSK 2189242A) in young adults.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Formulation 1	Experimental	Biological: Pneumococcal vaccine GSK2189242A (formulation 1)
Formulation 2	Experimental	Biological: Pneumococcal vaccine GSK2189242A (formulation 2)

Who may qualify

Ages: 18 to 41 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (10 listed)

Subjects who the investigator believes will comply with the requirements of the protocol should be enrolled in the study.
A male or female between, and including, 18 and 41 years old at the time of vaccination.
Subjects who previously participated in the study NCT00707798 and received one of the two investigational GSK2189242A vaccine formulations during the primary study.
Written informed consent obtained from the subject.
Free of obvious health problems as established by medical history, clinical examination and clinical laboratory assessment before entering into the study.

Key exclusion criteria (21 listed)

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the vaccination, or planned use during the study period.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to vaccination.
Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting 30 days prior to the vaccination and ending one month (minimum 30 days) after vaccination.
Administration of any pneumococcal vaccine other than the study vaccine during the period between end of study NCT00707798 and study vaccination.
Bacterial pneumonia within the period between end of study NCT00707798 and study vaccination.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Pneumococcal vaccine GSK2189242A (formulation 1)One dose will be administered intramuscularly at Study Day 0.	Biological	Formulation 1
Pneumococcal vaccine GSK2189242A (formulation 2)One dose will be administered intramuscularly at Study Day 0.	Biological	Formulation 2

Primary outcome

Number of Subjects With Grade 3 Solicited Local Symptoms
Time frame: During the 7-day (Days 0-6) post-booster vaccination period
Assessed solicited local symptoms were pain, redness and swelling. Grade 3 pain = significant pain at rest, pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.
Number of Subjects With Grade 3 and Vaccine-related Solicited General Symptoms
Time frame: During the 7-day (Days 0-6) post-booster vaccination period
Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (nausea, vomiting, diarrhoea and/or abdominal pain), headache, malaise, myalgia and fever [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = general symptom assessed by the investigator to be casually related to the study vaccination.
Number of Subjects With Grade 3 and Vaccine-related Unsolicited Adverse Events (AEs)
Time frame: During the 31-day (Days 0-30) post-booster vaccination period
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Number of Subjects With Any Vaccine-related Serious Adverse Events (SAEs)
Time frame: During the entire study period (from Day 0 to Day 30)
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Number of Subjects With Grade 3 Haematological or Biochemical Abnormalities
Time frame: At Days 1 and 6 post-booster vaccination
Among haematological or biochemical abnormalities assessed were: Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Cholesterol, Creatine Phosphokinase (CRP), Hemoglobin decrease, Haemoglobin, Lactate dehydrogenase (LDH), Neutrophils, Red blood cells (RBC), Reticulocytes, White blood cells (WBC) and Overall parameters. Assessment of intensity: Grading of the haematological and biochemical parameters was performed using the standard Food and Drug Administration (FDA) Toxicity Grading Scale. Changes compared to normal reference ranges were graded: Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening

7 secondary outcomes

Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (dPly) and Histidine Triad Protein D (PhtD) Proteins
Time frame: Prior to the booster vaccination (Day 0) and one month post-booster vaccination (Day 30)
Titers for Antibodies Against Pneumolysin Haemolysis (Hem-dPly) Protein
Time frame: Prior to the booster vaccination (Day 0) and one month post-booster vaccination (Day 30)
Number of Subjects With Any Solicited Local Symptoms
Time frame: During the 7-day (Days 0-6) post-booster vaccination period
Number of Subjects With Any Solicited General Symptoms
Time frame: During the 7-day (Days 0-6) post-booster vaccination period
Number of Subjects With Any Unsolicited AEs
Time frame: During the 31-day (Days 0-30) post-booster vaccination period
Number of Subjects With Any SAEs
Time frame: During the entire study period (from Day 0 to Day 30)
Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities
Time frame: At 1 and 6 days post-booster vaccination

Results and safety

Results posted to the registry on 19 Jul 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
GSK2189242A Formulation 1 Group	22	22
GSK2189242A Formulation 2 Group	21	21

Primary outcome: Number of Subjects With Grade 3 Solicited Local Symptoms

Time frame: During the 7-day (Days 0-6) post-booster vaccination period. Count of participants. Unit: Participants

Measure	GSK2189242A Formulation 1 Group n = 22	GSK2189242A Formulation 2 Group n = 21
Grade 3 Pain	0	1
Grade 3 Redness	0	1
Grade 3 Swelling	1	0

Population analysed: The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccine administration documented.

Primary outcome: Number of Subjects With Grade 3 and Vaccine-related Solicited General Symptoms

Time frame: During the 7-day (Days 0-6) post-booster vaccination period. Count of participants. Unit: Participants

Measure	GSK2189242A Formulation 1 Group n = 22	GSK2189242A Formulation 2 Group n = 21
Grade 3 Fatigue	1	0
Related Fatigue	3	13
Grade 3 Gastrointestinal symptoms	0	0
Related Gastrointestinal symptoms	3	0
Grade 3 Headache	0	0
Related Headache	5	8
Grade 3 Malaise	0	0
Related Malaise	2	3

Population analysed: The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccine administration documented.

Primary outcome: Number of Subjects With Grade 3 and Vaccine-related Unsolicited Adverse Events (AEs)

Time frame: During the 31-day (Days 0-30) post-booster vaccination period. Count of participants. Unit: Participants

Measure	GSK2189242A Formulation 1 Group n = 22	GSK2189242A Formulation 2 Group n = 21
Grade 3 AE(s)	1	1
Related AE(s)	1	1

Population analysed: The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccine administration documented.

Primary outcome: Number of Subjects With Any Vaccine-related Serious Adverse Events (SAEs)

Time frame: During the entire study period (from Day 0 to Day 30). Count of participants. Unit: Participants

Measure	GSK2189242A Formulation 1 Group n = 22	GSK2189242A Formulation 2 Group n = 21
Value	0	0

Population analysed: The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccine administration documented.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) follow-up period post-booster vaccination; SAEs: during the entire study period (from Day 0 up to Day 30).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GSK2189242A Formulation 1 Group	0 of 22 (0%)	21 of 22 (95.5%)	0 of 22
GSK2189242A Formulation 2 Group	0 of 21 (0%)	21 of 21 (100%)	0 of 21

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Subjects With Grade 3 Solicited Local Symptoms (time frame: During the 7-day (Days 0-6) post-booster vaccination period). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00896064.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2018.